From e-Survey to EDC

Recently, Karl and I attended a seminar presented by IBM SPSS titled "Predictive Perspectives" where they demonstrated their Data Collection Author product as well as several others.

Data Collection Author can help you create surveys. You can create one survey and deploy in many different modes (online, telephone, offline) and in any language.

While the presentation was underway, it brought up the question, "At what point does e-survey software become Electronic Data Capture (EDC) software?"

We are aware of a mushrooming number of e-survey products on the market today. A incomplete list of them might include:

SurveyMonkey, eSurveyspro, surveygizmo, QuestionPro, and SurveyMethods

Now, while we don't necessarily endorse any of these, we thought these vendors might consider further developing their offerings into EDC products. What would doing so entail? Might it be possible to create a low-cost EDC system using a well-designed e-survey application as a starting point?

Obviously, a lot of surveys are single-pass collection of unedited data from anonymous sources.

One would need to allow data editing. One might need more enhanced data cleaning power than that provided by form-level edit-checking and input masking (e.g., capture dates in consistent date format). One would need to identify the person entering data. With the ability to change data, comes the need for an audit trail.

In between e-surveys and full-fledged EDC systems, lies a range of applications that allow someone to select user preferences from a specific set of options. Examples of those would be a user profile or health benefit enrollment. These applications are often custom tailored and one-time use. Can e-survey software, with its user friendly authoring capability be extended into these areas in areas to offer a much more "generic" development/update environment?

Finally, EDC would require compliance to 21 CFR Part 11 software requirements - more specifically, the software requirements detailed in Section 11.10:

• Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records


• The ability to generate accurate and complete copies of records in both human readable and electronic form


• Protection of records to enable their accurate and ready retrieval throughout the records retention period


• Limiting system access to authorized individuals


• Use of secure, computer-generated, time-stamped audit trails


• Use of operational system checks to enforce permitted sequencing of steps and events


• Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand


• Use of device checks to determine the validity of the source of data input or operational instruction


• Determination that persons who develop, maintain, or use electronic record/electronic signature systems has the education, training, and experience to perform their assigned task


• The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures


• Use of appropriate controls over systems documentation

Adding all of this to an e-survey application would not be a trivial endeavor. Nor will it be complete since we haven’t mentioned the addition of other longtime Clinical Data Management System functions like autoencoding and site monitoring.

While we remain hopeful that advances in software will eventually allow the creation of a low-end EDC system, we remain skeptical that it will be "inexpensive".